Status:
COMPLETED
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma
Detailed Description
A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. This study was previously ...
Eligibility Criteria
Inclusion
- Subject, male or female, must be between the ages of 4 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start.
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
- Subject must have a chest X-ray or have one taken within 12 months prior to randomization may be used.
- Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis and understand dosing instructions. Any subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.
Exclusion
- Female subject who is pregnant or lactating.
- Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
- Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
- Subject using any prescription drug with which albuterol sulfate administration is contraindicated.
- Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior to study start.
- Subject with a history of cancer.
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
- Subject with a history of cigarette smoking or use of any tobacco products.
- Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start.
- Subject with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
- Subject who is a staff member or relative of a staff member.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00684866
Start Date
January 1 2003
End Date
July 1 2003
Last Update
February 22 2012
Active Locations (11)
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1
Madera, California, United States
2
San Diego, California, United States
3
Savannah, Georgia, United States
4
Louisville, Kentucky, United States